BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 7512148 · Received May 14, 2018

    Report

    Report Number
    1416980-2018-02849
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 18, 2018
    Report Date
    May 5, 2022
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    UDI-DI
    00085412081502
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO B5 AND D4: CATALOGUE #. B5: THE CORRECT AFFECTED PRODUCT IS ¿LARGE VOLUME MULTIRATE INFUSOR¿, PREVIOUSLY SUBMITTED AS ¿MULTIRATE INFUSOR¿. D4: THE CORRECT PRODUCT CODE IS ¿2C9961KP¿, PREVIOUSLY SUBMITTED AS IN2C9961KP. ADDITIONAL INFORMATION TO G4: 510K#. G4: 510K #: ¿K011317¿, PREVIOUSLY SUBMITTED AS ¿NA¿. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LOT WAS MANUFACTURED OCTOBER 11, 2017 - OCTOBER 12, 2017. THE ACTUAL SAMPLES WERE NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE ONE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE HOUSING WAS MALFORMED, WHICH LED TO THE COIL CAP SEPARATING FROM THE HOUSING. THE REPORTED CONDITION WAS VERIFIED FOR ONE SAMPLE. THE CAUSE OF THE MALFORMED HOUSING WAS DETERMINED TO BE EXPOSURE TO A VERY HIGH TEMPERATURE. THE SECOND SAMPLE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO (2) MULTIRATE INFUSORS WERE DISCOVERED TO BE IN DAMAGED CONDITION DURING UNPACKING. THIS EVENT OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354701 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE NA 17K025 00085412081502

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown